drugset / Trial / NCT03095521

A Local Clinical Study for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol] and ANTI-ANGIN® FORMULA, Lozenges, in Treatment of Patients With a Sore Throat

NCT03095521 ↗

Phase 3 Completed 228 enrolled Sandoz
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate no less therapeutic efficacy and safety of the Angal, lozenges \[Menthol\], 1 mg + 5 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, lozenges, 0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.

Timeline

Start
2017-02-22
Primary completion
2017-05-07
Completion
2017-05-07

Outcome

Met primary endpoint

registry analysis (non-inferiority test); ANGAL vs ANTIANGIN; p = 0.028; Fisher Exact NCT03095521 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator ANTI-ANGIN® FORMULA Unknown — —
Subject Angal Unknown — —

Indications